PMA N17600S029

Device: AVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S029
Product code: LMF
Decision date: 2014-06-26
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.

Current openFDA PMA Record#

Device: AVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S029
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-06-26
Decision code: OK30
Date received: 2014-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.